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NOT YET RECRUITING
NCT07193160
PHASE2

Sacituzumab Tirumotecan in Combination With Furmonertinib as Second-line Treatment for EGFR-mutant Advanced or Metastatic NSCLC After Failure of First-line Third-generation EGFR-TKI Therapy

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This study is a multicenter, single-arm, phase II clincial trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (sac-TMT) and Furmonertinib in the treatment of EGFR-mutant advanced or metastatic NSCLC after failure of first-line Third-generation EGFR-TKI therapy.

Official title: A Multicenter, Single-arm, Phase II Clinical Study of Sacituzumab Tirumotecan in Combination With Furmonertinib as Second-line Treatment for EGFR-mutant Advanced or Metastatic NSCLC After Failure of First-line Third-generation EGFR-TKI Therapy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2025-11-01

Completion Date

2027-05-30

Last Updated

2025-09-25

Healthy Volunteers

No

Interventions

DRUG

Sacituzumab Tirumotecan

fixed dosage 4mg/kg iv, D1, D15, each 4 weeks one cycle. Drug reduction will be implemented according to the research plan.

DRUG

Furmonertinib

160mg QD or 80mg QD, each 4 weeks one cycle, according to the safety run-in phase, until confirmed by the investigator as imaging disease progression, intolerable toxicity, subject's request to terrminate treatment, or other treatment termination criteria specified in the protocol. Drug reduction will be implemented according to the research plan.